The human eye in simplest terms functions to provide vision by transmitting light through a clear outer portion called the cornea, and focusing the image by way of a lens onto the retina. The quality of the focused image depends on many factors including the size and shape of the eye, and the transparency of the cornea and lens.
When age or disease causes the lens to become less transparent, vision deteriorates because of the diminished light which can be transmitted to the retina. This deficiency in the lens of the eye is medically known as a cataract. An accepted treatment for this condition is surgical removal of the lens and replacement of the lens function by an artificial intraocular lens (IOL).
In the United States, the majority of cataractous lenses are removed by a surgical technique called phacoemulsification. During this procedure, a thin phacoemulsification cutting tip is inserted into the diseased lens and vibrated ultrasonically. The vibrating cutting tip liquefies or emulsifies the lens so that the lens may be aspirated out of the eye. The diseased lens, once removed, is replaced by an artificial lens.
A typical ultrasonic surgical device suitable for ophthalmic procedures consists of an ultrasonically driven hand piece, an attached cutting tip, an irrigating sleeve, and an electronic control console. The hand piece assembly is attached to the control console by an electric cable and flexible tubing. Through the electric cable, the console varies the power level transmitted by the hand piece to the attached cutting tip and the flexible tubing supply irrigation fluid to, and draw aspiration fluid from, the eye through the hand piece assembly.
In use, the ends of the cutting tip and irrigating sleeve are inserted into a small incision of predetermined width in the cornea, sclera, or other location. The cutting tip is ultrasonically vibrated along its longitudinal axis within the irrigating sleeve by the crystal-driven ultrasonic horn, thereby emulsifying the selected tissue in situ. The hollow bore of the cutting tip communicates with the bore in the horn that in turn communicates with the aspiration line from the hand piece to the console. A reduced pressure or vacuum source in the console draws or aspirates the emulsified tissue from the eye through the open end of the cutting tip, the cutting tip and horn bores, and the aspiration line and into a collection device. The aspiration of emulsified tissue is aided by a saline flushing solution or irrigant that is injected into the surgical site through the small annular gap between the inside surface of the irrigating sleeve and the cutting tip.
Recently, a new cataract removal technique has been developed that involves the injection of hot (approximately 45° C. to 105° C.) water or saline to liquefy or gellate the hard lens nucleus, thereby making it possible to aspirate the liquefied lens from the eye. Aspiration is conducted concurrently with the injection of the heated solution and the injection of a relatively cool solution, thereby quickly cooling and removing the heated solution.
In the liquefracture technique of cataract removal, the cataractous lens is liquefied or emulsified by repetitive pulses of a surgical fluid that are discharged from the hand piece. The liquefied lens may then be aspirated from the eye. Since the surgical fluid is actually used to liquefy the cataractous lens, a consistent, pressurized source of surgical fluid is important to the success of the liquefracture technique. In addition, different surgical fluids may be advantageous for the removal of different hardness of cataracts or for various patient conditions.
Conventional ophthalmic surgical instrument systems use vacuum to aspirate the surgical site and positive pressure to irrigate the site. Typically, a cassette is serially connected between the means used to generate pressure and the surgical instrument. The use of cassettes with surgical instruments to help manage irrigation and aspiration flows at a surgical site is well known. U.S. Pat. Nos. 4,493,695 and 4,627,833 (Cook), U.S. Pat. No. 4,395,258 (Wang, et al.), U.S. Pat. No. 4,713,051 (Steppe, et al.), U.S. Pat. No. 4,798,580 (DeMeo, et al.), U.S. Pat. Nos. 4,758,238, 4,790,816 (Sundblom, et al.), and U.S. Pat. Nos. 5,267,956, 5,364,342 (Beuchat) and U.S. Pat. No. 5,747,824 (Jung, et al.) all disclose ophthalmic surgical cassettes with or without tubes, and they are incorporated in their entirety by this reference. Aspiration fluid flow rate, pump speed, vacuum level, irrigation fluid pressure, and irrigation fluid pressure, and irrigation fluid flow rate are some of the parameters that require precise control during ophthalmic surgery.
For aspiration instruments, the air pressure in the cassette is below atmospheric pressure, and fluid within the cassette has been removed from the surgical site. For irrigation instruments, the air pressure in the cassette is higher than the atmospheric pressure, and the fluid will be transported to the surgical site. In both types of instruments, the cassette acts as a reservoir for the fluid that buffers variations caused by the pressure generation means.
For the cassette to act as an effective reservoir, the level of fluid (and thus the empty volume) within the cassette must be controlled so that the cassette is neither completely filled nor emptied. If fluid fills the cassette in an aspiration system, fluid may be drawn into the means for generating vacuum (typically a venturi), which would unacceptably interfere with the vacuum level of the surgical instrument. An empty cassette in an aspiration system will result in air being pumped into the drain bag, which would waste valuable reservoir space within the bag. Moreover, constant volume within the cassette in an aspiration system enables more precise control level of vacuum within the surgical instrument. Control of the fluid level within cassettes of irrigation systems is similarly desirable.
Additionally, the size of the reservoir within the cassette affect the response time of the cassette. A larger reservoir provides more storage capacity but slows the response time of the system. A smaller reservoir increases the response time of the system, but may not have adequate storage capacity. This dilemma has been addressed by cassettes having two internal reservoirs. Such a cassette is illustrated in U.S. Pat. No. 4,758,238(Sundblom, et al.) (the “Sundblom Cassette”). The smaller reservoir is in direct fluid communication with the surgical handpiece while a larger reservoir is positioned between the smaller reservoir and the source of vacuum. This allows for a faster response time and larger storage capacity. The small reservoir, however, must be periodically emptied into the larger reservoir prior to the smaller reservoir filling up. This requires that the smaller reservoir contain a fluid level sensor that notifies the control console to empty the smaller reservoir at the appropriate time. The Sundblom Cassette uses two electrical probes 76 (see FIG. 8) that form an open electrical alarm circuit. When the surgical fluid (which is electrically conductive) fills small reservoir 30, both probes 76 are submersed in the fluid, thereby closing the circuit and triggering the alarm that reservoir 30 is full. The fluid level sensor used in the Sundblom cassette has the limitation of being a simple “On/Off” switch. The sensor has no other function other than to trigger a “reservoir full” alarm and provides no other information to the user about the amount of fluid in the small reservoir.
Other pressure sensors, such as the one disclosed in U.S. Pat. No. 5,747,824 (Jung, et al.) use an optical device for continuous fluid level sensing by reading the location of the air/fluid interface. These optical devices require relatively expensive phototransmitters and receivers and are subject to inaccuracies due to foaming of the fluid within the reservoir. In addition, the accuracy of optical pressure sensors can be affected by ambient light levels.
Acoustic pressure sensors have been used in the past to monitor the fluid level in water tanks. The ultrasound transducers are mounted within the tank at the top of the tank and an ultrasound signal is sent downward toward the top of the water contained within the tank. This arrangement, however, is not suitable for use with surgical equipment where sterility is important and the transducer cannot be allowed to come into contact with the fluid. In addition, as surgical devices generally are disposable, locating the transducer within the chamber is undesirable.
Accordingly, a need continues to exist for a simple reliable and accurate fluid level sensor.